LANGSTON IPN913559Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10841156100513), received between Apr 4, 2019 and Oct 29, 2020 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Separation Problem” (6 reports).

2 FDA recall records name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 31, 2020Class ITerminated

   The inner lumen of the Langston catheter may separate from the hub during pressure injection.

   Z-0111-2021 · Root cause: Process control · Recall details · FDA record ↗

2. Mar 16, 2020Class ITerminated

   The inner lumen of the Langston catheter may separate from the hub during pressure injection.

   Z-1747-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2020No Apparent Adverse Event; No Apparent Adverse Event

  PER RECEIVED MEDWATCH (B)(4). TFX REPORT (B)(4). THE LANGSTON CATHETER DRAWS BACK AIR WHILE IN THE PATIENT. UPON EXAMINATION, THERE IS A HOLE NEAR THE HUB. NO MEDICAL INTERVENTION REPORTED. NO COMPLICATONS REPORTED. ADDITIONAL INFORMATION RECEIVED 08OCT2020: FROM PROCEDURAL NOTES: A 6-FRENCH SIDEARM VIA MODIFIED SELDINGER TECHNIQUE TO BOTH RIGHT CFA AND CFV. PORTS FLUSHED AND ASPIRATED WELL. SELECTIVE CORONARY ANGIOGRAPHY PERFORMED WITH 6-FRENCH PREFORMED CATHETER. THE CATHETER WITH A SOFT STRAIGHT WIRE WAS REQUIRED TO CROSS THE CALCIFIC AOV, AFTER ABOUT 10 MIN AND CATHETER FLUSHED EVERY 2 MIN, THEN FELL INTO THE LEFT VENTRICLE EXCHANGED FOR LANGSTON FOR LEFT VENTRICULAR PRESSURES AND SUBSEQUENT LEFT HEART PULL BACK. VENTRICULOGRAM WAS PERFORMED IN THE THIRTY DEGREE RAO. THEN EXCHANGED THE RIGHT CFV SHEATH WITH CATHETER OVER A JWIRE AND ANCHORED IN POSITION W/2 SILK SUTURES. THEN EXCHANGE THE RIGHT CFA SHEATH FOR IABP SHEATH AND OVER JWIRE ADVANCED TO BULB UNDER FLUORO AND SET AT 1:1 WITH AUGMENTED SBP 140; ALL SHEATH AND CATHETERS REMOVED. SHEATH WAS SUTURED IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10755788 ↗
• MalfunctionAug 31, 2020Gas/Air Leak

  INCIDENT DESCRIPTION: THE LANGSTON CATHETER DRAWS BACK AIR WHILE IN THE PATIENT. UPON EXAMINATION, THERE IS A HOLE NEAR THE HUB. THE PROCEDURE WAS CARRIED OUT WITH NO COMPLICATIONS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10470991 ↗
• MalfunctionAug 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: LUMEN ABOVE THE DEVICE HUB BLEW OUT WHILE IN USE ON PATIENT. ADDITIONAL INFORMATION RECEIVED 17AUG2020: THE PATIENT IS DOING WELL. THE DEVICE WAS DISPOSED OF AFTER THE REPORTING. IT DID NOT HAPPEN DURING A POWER INJECTION. THE LUMEN DID NOT REQUIRE RETRIEVAL OR USE OF A SNARE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10448564 ↗
• MalfunctionJul 28, 2020Detachment of Device or Device Component

  ELDERLY MALE WITH HISTORY OF HYPERTENSION, SEVERE AORTIC STENOSIS AND CHEST PAIN. WHILE HAVING A HEART CATH, THE STOPCOCK FELL OFF THE CATHETER AND WOULD NOT STAY ON. NO KNOWN HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331775 ↗
• MalfunctionMar 19, 2020Separation Problem; Separation Problem

  AS REPORTED: CUT DOWN AXILLARY TAVR. USED THE LANGSTON IN THE RIGHT RADIAL ARTERY INSTEAD OF GETTING ANY GROIN ARTERY ACCESS. WE GOT RADIAL ACCESS TO USE A LANGSTON FOR INJECTIONS AND PRESSURES. WE TOOK ONE INJECTION OF THE AO. WE WENT TO REPOSITION THE CATHETER WITH THE J TIP WIRE. THE PHYSICIAN REALIZED THE WIRE WAS NOT COMING OUT OF THE PIGTAIL OF THE CATHETER. THE CATHETER WAS REMOVED FROM THE ARM VIA OVER THE WIRE. WHEN CATHETER WAS PULLED OUT THE INNER LUMEN WAS STILL IN THE ARM. ALL OF LANGSTON WAS REMOVED WITH NO INJURY OR ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9856735 ↗
• MalfunctionMar 19, 2020Separation Problem; Separation Problem

  AS REPORTED, LANGSTON CATHETER WAS BEING ADVANCED IN THE DESCENDING AORTA AND CARDIOLOGIST WAS HAVING DIFFICULTY ADVANCING, SO DECIDED TO PULL IT OUT AND IT WAS SPLIT ONCE HE SAW IT OUT OF THE BODY. NO FRAGMENTS NEEDED TO BE RETRIEVED, CATHETER CAME OUT INTACT. NO POWER INJECTION WAS PERFORMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9853363 ↗
• MalfunctionMar 6, 2020Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE CATHETER RUPTURED DURING AN LV GRAM. THE CATHETER FRACTURED IN BETWEEN THE HUB AND THE Y PORT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9801352 ↗
• MalfunctionFeb 7, 2020Separation Problem; Separation Problem

  IT WAS REPORTED THAT A POWER INJECTION WAS DONE AT 800 PSI AND THE CATHETER FRACTURED IN BETWEEN THE HUB AND THE Y PORT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9681779 ↗
• MalfunctionFeb 7, 2020Separation Problem; Separation Problem

  IT WAS REPORTED THAT A POWER INJECTION WAS DONE AT 800 PSI AND THE CATHETER FRACTURED IN BETWEEN THE HUB AND THE Y PORT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9681728 ↗
• InjurySep 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNDERLYING CONDITIONS OF THE PATIENT, COMBINED AORTIC VALVE VITIUM IN MODERATE AORTIC VALVE STENOSIS AND AORTIC VALVE INSUFFICIENCY, SEVERE CORONARY SCLEROSIS, SEVERE PELVIC LEG ARTERY KINKING. NURSE REPORTED THAT THE TIP OF THE CATHETER WAS TORN OFF DURING PROCEDURE AND WAS FLUSHED THROUGH THE CIRCULATORY SYSTEM INTO THE GROIN UNDER FLUOROSCOPY AND COULD BE SECURED AND REMOVED BY THE SENIOR PHYSICIAN AT THIS POSITION. A LARGER SHEATH WAS PLACED, THEN FIXED BY A LASSO CATHETER AND THEN REMOVED FROM THE GROIN TOGETHER WITH THE SHEATH. PATIENT IS REPORTED AS DOING FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9088314 ↗
• MalfunctionSep 11, 2019Separation Problem; Separation Problem

  CATHETER SPLIT NEAR THE HUB AFTER POWER INJECTION. 900PSI 24 FOR 12. NO PATIENT INJURY OR IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8994935 ↗
• InjuryAug 7, 2019Material Fragmentation; Material Fragmentation

  DR. PERFORMED LANGSTON INTRODUCTION AS USUAL THROUGH THE RIGHT RADIAL ACCESS POINT. ANATOMY WAS TORTUOUS IN THIS PATIENT, BUT NOT OUT OF THE ORDINARY FOR THIS APPROACH. JWIRE AND TIG WERE USED TO CROSS THE VALVE. THE TIG CAME OUT, LEAVING JUST THE WIRE. THE LANGSTON WAS INTRODUCED OVER THE WIRE. THE WIRE WAS REMOVED. TRANSDUCER MEASUREMENTS WERE TAKEN. THE WIRE WAS REINTRODUCED INTO LANGSTON FOR REMOVAL. THE WIRE STOPPED/WOULD NOT ADVANCE ALL THE WAY INTO THE LANGSTON. ON THE IMAGE IS WAS OBSERVED THE LANGSTON HAD BENT/KINKED AT ONE OF THE CURVED AREAS - THE DISTAL SUBCLAVIAN ARTERY. THE WIRE COULD NOT BE ADVANCED PAST THE BENT PORTION, EVEN WITH SOME MANIPULATION TECHNIQUES. EVENTUALLY WHEN THE WIRE WAS ATTEMPTED TO BE PUSHED THROUGH IT CAUSED SEPARATION OF THE TIP OF THE LANGSTON AT THE BEND POINT. IN ORDER TO RETRIEVE THE DETACHED LANGSTON TIP (ABOUT 3.5" IN LENGTH) A NEW ACCESS POINT WAS CREATED IN THE GROIN WITH AN 8F SHEATH. A SNARE WAS USED THROUGH THIS ACCESS SITE TO SUCCESSFULLY RETRIEVE THE DETACHED TIP.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8868669 ↗
• MalfunctionJul 26, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THERE WAS AIR LEAKAGE AT PROXIMAL END OF CATHETER. THE PROCEDURE BEING PERFORMED WAS A RIGHT AND LEFT HEART CATH. THE DEVICE WAS INSPECTED PRIOR USE AND THERE WAS NO VISUAL DAMAGE TO THE HUB. ALL THE FITTINGS CHECKED WERE SECURE SO THAT AIR WOULD NOT BE INTRODUCED INTO THE CATHETER DURING USE AND RECHECKED SEVERAL TIMES. THE CATHETER WAS FLUSHED PRIOR TO USE. THERE WAS NO ADVERSE IMPACT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830760 ↗
• MalfunctionApr 4, 2019No Apparent Adverse Event; No Apparent Adverse Event

  UPON ASPIRATION DOCTOR NOTICE AIR IN THE DISTAL END OF THE PIGTAIL. ADDITIONAL INFORMATION RECEIVED 12MAR19: THE LANGSTON WAS INSIDE THE PATIENT AND THE TECHNICIAN ATTACHED A SYRINGE TO THE HUB OUTSIDE THE PATIENT, PULLED BACK TO ASPIRATE AT WHICH POINT AIR WAS NOTICED IN THE CATHETER LINE OUTSIDE THE BODY. TO CLARIFY, THE AIR WAS NOT OBSERVED IN THE PATIENT'S ANATOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8482925 ↗